90 Participants Needed

Miniaturized Percutaneous Nephrolithotomy for Kidney Stones

MM
Overseen ByMarina Markovic
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on blood thinners (anticoagulants), you may not be eligible to participate.

Is miniaturized percutaneous nephrolithotomy generally safe for humans?

Research shows that miniaturized percutaneous nephrolithotomy (mini-PCNL) is generally safe for removing kidney stones, with studies comparing different sheath sizes and techniques indicating good safety profiles in both adults and children.12345

How is miniaturized percutaneous nephrolithotomy different from other treatments for kidney stones?

Miniaturized percutaneous nephrolithotomy (PCNL) uses smaller sheaths compared to conventional PCNL, which reduces the risk of complications and improves recovery while maintaining effectiveness in removing kidney stones.56789

What data supports the effectiveness of the treatment Miniaturized Percutaneous Nephrolithotomy for Kidney Stones?

Research shows that miniaturized percutaneous nephrolithotomy (mini-PCNL) is effective for removing kidney stones while reducing complications compared to the standard procedure. The use of vacuum-assisted access sheaths in mini-PCNL has been introduced as a new method to enhance the treatment's effectiveness.5691011

Who Is on the Research Team?

SS

Sriharan Sivalingam

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for adults over 18 with kidney stones sized between 10-25 mm, who can consent and meet study requirements. It's open to all ethnicities and genders. Those with a nephrostomy tube or ureteral stent already in place may join. People on blood thinners, with coagulation disorders, congenital kidney anomalies, previous kidney surgeries, or needing multiple access tracts are excluded.

Inclusion Criteria

I am scheduled for a specific kidney stone surgery and had a special CT scan before.
I am willing and able to follow the study's requirements.
It's okay if you already have a tube in your kidney or ureter.
See 4 more

Exclusion Criteria

I have had surgery before on the same side of my upper urinary tract.
I am able to understand and agree to the study's requirements.
My surgery was changed to an open procedure.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo miniaturized percutaneous nephrolithotomy using either a vacuum-assisted or standard sheath

1 day
1 visit (in-person)

Post-operative Hospital Stay

Participants remain in the hospital for recovery and monitoring after the procedure

1-2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up appointment approximately 4-6 weeks post-surgery

4-6 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Conventional Sheaths
  • Miniaturized Percutaneous Nephrolithotomy
  • Vacuum-Assisted Access Sheaths
Trial Overview The study compares two surgical methods for removing kidney stones: one using a vacuum-assisted sheath and the other using a conventional sheath during mini-PCNL (a minimally invasive surgery). The goal is to determine which method is more effective for patients like you.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: passive suction via conventional sheathActive Control2 Interventions
Group II: vacuum-assisted sheathActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Published Research Related to This Trial

In a study of 136 patients, vacuum-assisted percutaneous nephrolithotomy (Va-PCNL) demonstrated a significantly shorter operative time (95 minutes) compared to standard mini-PCNL (146 minutes), making it a more efficient option for kidney stone treatment.
Both Va-PCNL and mini-PCNL had similar stone-free rates (around 72%) and complication rates, but Va-PCNL resulted in a shorter hospital stay (1.7 days vs. 2.7 days), indicating it may offer advantages in recovery time without compromising safety or efficacy.
Vacuum-assisted access sheath in supine mini-percutaneous nephrolithotomy (mini-PCNL).Szczesniewski, JJ., Boronat Catalá, J., García-Cano Fernández, AM., et al.[2023]
Mini-percutaneous nephrolithotomy, using a smaller 13F ureteroscopy sheath, aims to lower the morbidity associated with standard percutaneous nephrolithotomy while still effectively removing kidney stones.
This technique may help prevent the unnecessary deferral to less effective procedures, potentially reducing the overall number of treatments and healthcare costs for patients with renal calculi.
Mini-percutaneous nephrolithotomy.Chan, DY., Jarrett, TW.[2016]
The miniaturized nephrolithotomy (mini-perc) technique achieved a high stone-free rate of 90.1% after one procedure and 98% after additional treatment, making it an effective option for managing renal stones smaller than 20 mm.
This minimally invasive procedure had a low overall complication rate of 6.86%, with no severe complications reported, and resulted in minimal hemoglobin loss, indicating a safe profile compared to conventional methods.
Mini-Perc for Renal Stones-A Single Center Experience and Literature Review.Cauni, VM., Dragutescu, M., Mihai, B., et al.[2023]

Citations

Vacuum-assisted access sheath in supine mini-percutaneous nephrolithotomy (mini-PCNL). [2023]
Mini-percutaneous nephrolithotomy. [2016]
Mini-Perc for Renal Stones-A Single Center Experience and Literature Review. [2023]
Updated evidence of the safety and efficacy of the miniaturized percutaneous nephrolithotomy with holmium laser lithotripsy for the treatment of recurrent nephrolithiasis. [2022]
Mini versus ultra-mini percutaneous nephrolithotomy in a paediatric population. [2022]
Minipercutaneous nephrolithotomy. [2022]
Comparison of vacuum-assisted sheaths and normal sheaths in minimally invasive percutaneous nephrolithotomy: a systematic review and meta-analysis. [2022]
Comparison between standard, mini and ultra-mini percutaneous nephrolithotomy for single renal stones: a prospective study. [2022]
The "mini-perc" technique of percutaneous nephrolithotomy with a 14-Fr peel-away sheath: 3-year results in 72 patients. [2018]
Ultra-mini-percutaneous nephrolithotomy: A minimally-invasive option for percutaneous stone removal. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Precision Stone Surgery: Current Status of Miniaturized Percutaneous Nephrolithotomy. [2021]
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